Submission to the Department of Health (Fed) regarding Biosimilar Uptake Drivers Implementation This joint submission is made by: The Society of Hospital Pharmacists of Australia (SHPA) SHPA is the national professional organisation with more than 4,400 pharmacists, pharmacist interns, students, technicians and associates working across Australia s health system and are supported by Branches around the country. SHPA members lead the Pharmacy Departments at 29 of the principal referral hospitals in Australia, as well as the vast majority of both Public Acute A and Public Acute B hospitals. Council of Australian Therapeutic Advisory Groups (CATAG) CATAG is an authoritative, expert, consensus-based collaboration of representatives from all Australian State and Territory Therapeutic Advisory Groups or their jurisdictional committee equivalents New South Wales Therapeutic Advisory Group (NSWTAG) The New South Wales Therapeutic Advisory Group Inc. (NSW TAG) is an independent, not-for-profit member-based organisation, comprised of clinical pharmacologists, pharmacists, nurses and clinicians committed to advancing quality use of medicines (QUM) in NSW public hospitals and the wider community.
Introduction On behalf of our members, SHPA, CATAG, and NSWTAG welcome the opportunity to give advice on proposed uptake drivers to improve the use of biosimilars. CATAG, NSW TAG and SHPA recognise strategies and policies to increase the uptake of biosimilars have been implemented internationally and the Australian Department of Health is similarly facilitating subsidised access to these medicines in a fiscally-restrained environment. CATAG, NSW TAG and SHPA acknowledge that biological medicines are innovative, effective medicines that come at great cost to the community and, in principle, support the government s platform to maximise cost-effectiveness of all medicines funded by government. The acute care sector treats and manages the most unwell patients, who may require hospitalisation and specialist review. Innovative biological medicines are frequently initiated and monitored in these acute care environments. Further consideration needs to be given to the implications and practicalities of implementing these policies in the acute sector, particularly the impact upon resources. Optimising safe, effective and cost-effective use of all medicines is key for all stakeholders, including hospitals and we, in principle, support policies that will increase the uptake of biosimilars in anticipation that this will mean greater patient access to biological medicines and reduction in opportunity costs to other innovative medicines. Timeline of changes and implementation period It is not apparent when all the described changes will be implemented and how each stakeholder is required to respond and prepare for these changes. Given all the concerns raised below, we believe adequate lead time is required to ensure appropriate understanding and implementation from all stakeholders. For example, implementation of changes by the Department of Health to the reimbursement of chemotherapy compounders, which were discussed in 2015, has taken well over a year as it was recognised that hasty implementation would lead to signification confusion amongst stakeholders. Clarification is needed for stakeholders to understand whether the changes will be retrospective in terms of the medicines already listed on the PBS or will they only affect medicines newly listed on the PBS? Future discussions regarding development and implementation of drivers for biosimilar uptake We believe that in future, consultation with key stakeholders in the acute care sector, such as SHPA, CATAG and NSW TAG, prior to the agreements would have allowed a better understanding of the implications and practicalities of implementing these policies. Our three organisations would welcome further discussions with the Department about use of biosimilars, drivers for uptake and implementation strategies, to ensure their success in the acute care sector. The parties engaged in reaching the strategic agreements with the Department of Health do not represent the acute care sector, and thus are potentially unable to quantify and understand all the impacts proposed policies have upon key stakeholders. Page 2 of 6
Education required for all stakeholders CATAG, NSW TAG and SHPA believes that a clear implementation strategy, that includes an education campaign targeted at all stakeholders should be developed. We believe that the proposed non-clinical mechanisms to increase the uptake of biosimilars will be effective drivers; however, we note the significant and unprecedented change in the use of the PBS authority system as a driver of uptake. Previously the use of the authority system has aimed to ensure quality use of medicines considerations such as ensuring appropriate use and monitoring. The change based on non-clinical grounds has the potential for causing mistrust and confusion amongst prescribers. The benefits of greater biosimilar uptake to the health care system and patient care will need to be clearly articulated to stakeholders. Hospital clinicians are very familiar with rationing of medicines based on costs. However, changes to access to certain new medicines can meet resistance by clinicians when the evidence for bioequivalence is deficient, particularly with medicines used in immunological conditions. There can also be perverse incentives to maintain access to previously supported medicines. Experience with the introduction of earlier originator biological medicines and biosimilars in Australia in a case study format and provision of the evidence for interchangeability will assist uptake of biosimilars. Moreover, many hospitals are likely to be keen and early users of biosimilars given the cost savings. At first view, the proposed driver using the PBS authority system to increase biosimilar uptake appears to be inconsistent with the policy of listing equivalent medicines on the PBS. However, given a key principle for PBS listing of medicines is cost effectiveness, we believe that implementation of this specific driver should be promoted highlighting this principle. It is also reasonable to include background information about international strategies for increasing uptake noting that Australia is following their international counterparts in this area. International strategies have been implemented addressing both demand and supply 1, and there is some evidence to suggest policies targeting demand (i.e. measures directed at stakeholders who prescribe, dispense, and ask for medicines) positively impact the uptake of biosimilars. Additionally, we believe it is important that the Department of Health ensures that stakeholders understand the outcomes of the policy and how its effectiveness will be assessed and monitored and over what time period. Displays of increased uptake due to changed behavior (e.g. a dashboard display on the PBS website) and messaging using a nudge approach may also be helpful. Delivering effective education within hospitals utilising the existing hospital pharmacist network about the nature of biosimilarity and concepts such as interchangeability could be an efficient use of resources. Many biological medicines are initiated in acute care settings by specialists. In these settings, pharmacists play a key role in assisting doctors to navigate drug procurement, formulary applications and PBS requirements and decisions. Pharmacists influence prescribing behaviour through their engagement in healthcare teams and therefore would be in an ideal position to disseminate and provide education on the strategic changes proposed. To ensure national consistency of the education delivered, pre-designed presentations (PowerPoint) and written materials should be developed. 1 J Mark Access Health Policy. 2017; 5(1): 1307315. Published online 2017 Apr 28. doi: 10.1080/20016689.2017.1307315 Page 3 of 6
Uptake Driver One - Treatment Naïve Patients Treatment initiation in hospitals Given the severity of conditions that require treatment with biological medicines, treatment initiation with biological medicines often occurs in the acute care setting (either as inpatient or outpatient). Due to various factors, there is often only one particular brand of a biological/biosimilar medicine available through the hospital pharmacy due to individual hospital or health network formularies. Furthermore, in our experience, specialists who have had treatment success with certain biologics/biosimilars can be reluctant to change, and this is often supported by patients (and their carers) who can have resistance to perceived treatment changes for serious conditions. This driver for biosimilar uptake merely stating the government policy in the PBS listing notes will likely be of limited value to hospital clinicians prescribing for inpatients. It will have more influence on PBS prescribing for outpatients. However, these prescribers will also be mindful of the brand of biological medicine on the hospital formulary and the relevant Drug and Therapeutics Committee s policy regarding the prescription of the required biological medicine. (This will likely have been informed by the CATAG Overseeing biosimilar use: Guiding principles for the governance of biological and biosimilars in Australian Hospitals version 2-September 2016). Terminology The terminology in the Note in the Schedule of Pharmaceutical benefits sounds subjective and nonscientific: the use of recommended on a cost-effective basis or possibly encouraged rather than preferred. A caveat could be included: Prescribing of biosimilar brands is recommended to ensure cost effectiveness and to maintain a sustainable healthcare system. Prescribing in hospitals predominantly handwritten Although electronic medical records and medicines management platforms are being rapidly implemented in many public and private healthcare facilities, changes to prescribing software may have limited value in the foreseeable future given that most prescriptions issued in the hospital setting are handwritten on PBS stationery. Moreover, many medical specialists have been slow in adopting electronic prescribing software so software changes to prescribing software are likely to have limited impact on their prescribing in the foreseeable future. Any investment by the federal government into prescribing software should be inclusive of all programs used in the hospital setting for prescribing. Page 4 of 6
Uptake Driver Two Lower Authority for Prescribing Modification of the PBS Authority system Whilst we support and understand the need for government to rationalise spending on PBS medicines, we are unsure whether using the PBS Authority system is the most appropriate way to achieve this. For example, we note that reference brands such as Neupogen and Eprex are currently streamlined authority medicines. However, if the proposal is retrospective, implementation of this driver would suggest that these reference brands would be switched to written authority medicines. Historically, whether a written authority or streamlined authority is required for PBS listing of a medicines has been predominantly based on assessments of clinical factors, prescribing controls and risks, and patient safety. The modification of the PBS authority system to incorporate cost minimisation strategies within the same biological medicines that had previously been endorsed as interchangeable will need to be clearly outlined to stakeholders particularly prescribers and specialist clinicians. Collaboration with the relevant specialist colleges to promote the reason for this driver amongst their members is strongly recommended. Removal of a-flagging of biologicals While we understand the reason for removal of a-flagging, this will potentially cause significant confusion amongst clinicians. Under the current proposal, a medicine which had previously been assessed as interchangeable and approved for substitution by the TGA and PBAC will have the a-flag removed, no longer allowing substitution. However, in the hospital setting, this medicine may well continue to be classified as interchangeable and switching allowed. Clinicians generate their own individual formulary and practices through experience and familiarity with prescribing and dispensing medicines. These medicines are the clinician s priority drugs for a given indication. The removal of a-flagging may impact upon individual clinician formularies and therefore communicating this issue will be of particular importance. Impractical and burdensome to implement in some hospitals and health networks Hospitals typically stock only one brand of medicine. Where possible, contracts for supply of this brand will be in place as these provide protection against price increases and shortages. These contracts are nonnegotiable in the short-term. The scenario where access to a biological medicine could move from streamlined authority to written authority because the originator brand is the only brand stocked by the hospital will increase inefficiency, may cause confusion and add to prescriber frustration in time-poor, busy hospital-based clinical practice. Such a move is likely to be met with significant disapproval by specialist prescribers, who will be forced to engage in lengthy process to obtain approval. Page 5 of 6
Other considerations In addition, the naming of biological medicines including biosimilars may have an impact on the uptake of biosimilars. Further consideration of the impact of biosimilar nomenclature should be considered prior to implementation of drivers. SHPA, CATAG and NSW TAG support the implementation of a barcoding system similar to that recommended in the European Union (see TGA Consultation: Nomenclature of Biological Medicines, July 2017). Introduction of suffixes for the different biologicals medicine and their biosimilars will add further confusion to consumers, prescribers, pharmacists and other clinicians. If you have any queries or would like to discuss this submission further, please do not hesitate to contact Johanna de Wever, General Manager, Advocacy and Leadership at SHPA at jdewever@shpa.org.au, or Jane Donnelly, CATAG Co-ordinator at catag@stvincents.com.au, or Dr Alexandra Bennett, NSW TAG at nswtag@stvincents.com.au. Yours sincerely Kristin Michaels Chief Executive, SHPA Associate Professor Christopher Etherton-Beer Chair, CATAG Dr Alexandra Bennett Executive Officer, NSW TAG Page 6 of 6